STUDY OF STABILITY AND LABELING REQUIREMENTS OF INHALATION AND NASAL PRODUCT IN US AND EUROPE

Darshil B. Shah*, Deval K. Shah, Dr. Dilip G. Maheshwari

ABSTRACT

Inhalation and Nasal products are used in the Asthma and COPD so it requires precise regulation. Stability studies ensure the maintenance of product quality throughout the shelf life that is pre-requisite for the acceptance and approval of Inhalation and Nasal product. Stability studies play an important role in Inhalation development, possibly more than other delivery systems. These studies are required to conduct in a planned approach following the rules issued by ICH. Labeling is essential for any pharmaceutical product as it gives all the detail about the product which will be benefit for patient. Label facilitate manufacturer to market their product and catch people’s attention. It is useful to Consumer additionally to allow them distinguish the product form one another. In this article Stability studies which are required for Inhalation and Nasal product are same for both the countries. By studying the stability guideline we can easily find out the shelf life of the product and it is necessary for pharmaceutical companies to file their product in US and Europe. And labeling requirement which is essential for Inhalation and Nasal product are given in both the countries.

Keywords: Stability Requirements, labeling, Stability studies, ICH, Inhalation and Nasal product.